MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD GOLD KNITTED; VASCULAR POLYESTER GRAFT

Model Number	M002020851680
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
((b)(4)) a review of the complaint device history records indicated that the graft was processed and inspected according to established tests and procedures and no anomaly was found.((b)(4)) no conclusion can be drawn since the product remained implanted.However, the event root cause is highly probably due to a human error.Therefore, a non conformance report has been initiated.
Event or Problem Description
It was reported that on (b)(6) 2017, during a vascular surgery, after suturing the proximal portion and declamping the graft, a small pin hole at the bifurcation of the graft was noticed, causing some weeping.The physician took a 5.0 prolene suture and repaired the hole, the graft remained implanted.The surgery was completed without any adverse consequence for the patient.

• Brand Name: HEMASHIELD GOLD KNITTED
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6394682
• Report Number: 1640201-2017-00004
• Device Sequence Number: 33774
• Product Code: MAL
• UDI-Device Identifier: 00384401017721
• UDI-Public: 00384401017721
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K954848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/31/2021
• Device Model Number: M002020851680
• Device Catalogue Number: M002020851680
• Device Lot Number: 16D13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention